Skill required: Clinical Data Operations - Clinical Database Testing
Designation: Clinical Data Svs Associate Manager
Qualifications:Bachelor's in actuarial science/Master's in actuarial science
Years of Experience:10 to 14 years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world's largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
What would you do You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience. The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements. Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports.
What are we looking for Experience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning
Roles and Responsibilities:
- In this role you are required to do analysis and solving of moderately complex problems
- Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures
- The person requires understanding of the strategic direction set by senior management as it relates to team goals
- Primary upward interaction is with direct supervisor or team leads
- Generally interacts with peers and/or management levels at a client and/or within Accenture
- The person should require minimal guidance when determining methods and procedures on new assignments
- Decisions often impact the team in which they reside and occasionally impact other teams
- Individual would manage medium-small sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
- Please note that this role may require you to work in rotational shifts
